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NCT00981058 · OUTCOME

Number of Participants With an Epidermal Growth Factor Hormone (EGFR) Protein Expression Measured by Immunohistochemistry (IHC)

First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin · Source last updated 2025-06-18

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
31 Months

What was measured

EGFR IHC Histoscore H-score = weighted sum of % 1+ cells, twice % 2+ cells, and three times % 3+ cells. IHC H-score criteria was used to assess participants with a low EGFR expression defined by a H-score cutoff value of \<200 and participants with a high EGFR expression defined by a H-score of cutoff value of \>=200.

Analysis population: All randomized participants who received at least one dose of study drug and had evaluable data for EGFR IHC.

Groups in this outcome

Necitumumab + Gemcitabine + Cisplatin

Necitumumab + Gemcitabine + Cisplatin Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle. Continues until progressive disease, toxicity, noncompliance, or withdrawal. Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle. Continues for a maximum of six cycles. Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle. Continues for a maximum of six cycles.

Gemcitabine + Cisplatin

Gemcitabine + Cisplatin Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle. Continues for a maximum of six cycles. Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle. Continues for a maximum of six cycles.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Necitumumab + Gemcitabine + Cisplatin486
Gemcitabine + Cisplatin496

Reported measurements

0
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Necitumumab + Gemcitabine + Cisplatin24Not reportedNot reportedNot reportedNot reported
Gemcitabine + Cisplatin23Not reportedNot reportedNot reportedNot reported
>0
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Necitumumab + Gemcitabine + Cisplatin462Not reportedNot reportedNot reportedNot reported
Gemcitabine + Cisplatin473Not reportedNot reportedNot reportedNot reported
<200
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Necitumumab + Gemcitabine + Cisplatin295Not reportedNot reportedNot reportedNot reported
Gemcitabine + Cisplatin313Not reportedNot reportedNot reportedNot reported
≥200
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Necitumumab + Gemcitabine + Cisplatin191Not reportedNot reportedNot reportedNot reported
Gemcitabine + Cisplatin183Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        24
      2. group Id
        OG001
        value
        23
    title
    0
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        462
      2. group Id
        OG001
        value
        473
    title
    >0
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        295
      2. group Id
        OG001
        value
        313
    title
    <200
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        191
      2. group Id
        OG001
        value
        183
    title
    ≥200
denoms
  1. counts
    1. group Id
      OG000
      value
      486
    2. group Id
      OG001
      value
      496
    units
    Participants
description
EGFR IHC Histoscore H-score = weighted sum of % 1+ cells, twice % 2+ cells, and three times % 3+ cells. IHC H-score criteria was used to assess participants with a low EGFR expression defined by a H-score cutoff value of \<200 and participants with a high EGFR expression defined by a H-score of cutoff value of \>=200.
groups
  1. description
    Necitumumab + Gemcitabine + Cisplatin Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle. Continues until progressive disease, toxicity, noncompliance, or withdrawal. Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle. Continues for a maximum of six cycles. Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle. Continues for a maximum of six cycles.
    id
    OG000
    title
    Necitumumab + Gemcitabine + Cisplatin
  2. description
    Gemcitabine + Cisplatin Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle. Continues for a maximum of six cycles. Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle. Continues for a maximum of six cycles.
    id
    OG001
    title
    Gemcitabine + Cisplatin
param Type
NUMBER
population Description
All randomized participants who received at least one dose of study drug and had evaluable data for EGFR IHC.
reporting Status
POSTED
time Frame
31 Months
title
Number of Participants With an Epidermal Growth Factor Hormone (EGFR) Protein Expression Measured by Immunohistochemistry (IHC)
type
SECONDARY
unit Of Measure
participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice